Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pharmion has reported that the European Medicines Agency has accepted to review the company's marketing authorization application under the Accelerated Assessment Procedure, for Vidaza in patients with higher-risk myelodysplastic syndromes.
Subscribe to our email newsletter
The application is based upon clinical data which include the results from the company’s Phase III multi-center, international, randomized study of Vidaza (azacitidine for injection) in the treatment of patients with higher-risk myelodysplastic syndromes (MDS). The primary objective of this Phase III trial was to demonstrate superiority in overall survival of Vidaza versus conventional care regimens.
Vidaza has been designated as an orphan medicinal product in the EU for the treatment of MDS, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Vidaza has also been designated as an orphan medicinal product in the EU for the treatment of acute myeloid leukemia.